Current approaches to toxicity testing and safety assessment rely on traditional studies that evaluate observable outcomes in whole animals, such as clinical signs or pathological changes that are indicative of a disease state, and have changed very little over the last several decades. (See., e.g., Modernizing Toxicity for Drug Development, Hosapple, et al., Drug Discovery and Development, Apr. 12, 2012.) However, despite the methods currently used to screen potential therapeutics, more than 30% of drugs are eventually removed from the market due to adverse cardiac effects.
Accordingly, cardiotoxicity has become a central focus of drug development. Defining the relationship between molecular and adverse events so that researchers can identify and characterize the critical pathways involved with pathologies and organ system failures is of emerging importance in drug development. Accordingly, there is a need in the art to define such relationships so as to allow improved drug development.